CN1857654A - Trachaitis treating preparation and its preparing process - Google Patents
Trachaitis treating preparation and its preparing process Download PDFInfo
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- CN1857654A CN1857654A CN 200610065249 CN200610065249A CN1857654A CN 1857654 A CN1857654 A CN 1857654A CN 200610065249 CN200610065249 CN 200610065249 CN 200610065249 A CN200610065249 A CN 200610065249A CN 1857654 A CN1857654 A CN 1857654A
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Abstract
The present invention relates to Chinese medicine composition, and especially a kind of Chinese medicine composition for treating external wind and cold caused bronchitis, lung-heat cough, asthma, throat itching, excessive salivation, and senile phlegm dyspnea. The Chinese medicine composition is preferably prepared into dripping pill and soft capsule.
Description
Technical field:
The present invention relates to a kind of Chinese medicine composition and preparation technology thereof, particularly a kind ofly be used for the trachea inflammation that affection of exogenous wind-cold causes, the cough due to lung-heat, tachypnea asthma is itched in the larynx, accumulation and obstruction of sputum, chest and diaphragm is full vexed, the prescription of old phlegm dyspnea and preparation technology thereof.
Background technology:
The trachea inflammation that affection of exogenous wind-cold causes, the cough due to lung-heat, tachypnea asthma is itched in the larynx, accumulation and obstruction of sputum, chest and diaphragm is full vexed, and old phlegm dyspnea is clinically to see that symptom, the traditional Chinese medical science often take the means of cold expelling antitussive, eliminating phlegm relieving asthma that it is treated more, and evident in efficacy.Tracheitis pill is that it represents medicine.But in the practice, because this medicine is medical material to be beaten powder be used as medicine in preparation, cause impurity many, shortcoming such as dosage is big has a strong impact on its clinical practice.
The preparation of process extraction process preparation of the present invention is easy to dissolving and absorption than elite and thick putting that ordinary pill more can collect medicine, and curative effect is fast, and administration time is short, and therefore, curative effect is better.
The purpose of this invention is to provide a kind of therapeutic domain wide, easily accept, easily absorb, the preparation technology of efficient, low dosage, the Chinese medicine dripping pills that has no side effect, soft capsule, granule, chewable tablet, its pill that makes can be used for curing mainly the trachea inflammation that affection of exogenous wind-cold causes, the cough due to lung-heat, tachypnea asthma, itch in the larynx, accumulation and obstruction of sputum, chest and diaphragm is full vexed, old phlegm dyspnea.
Summary of the invention:
The present invention relates to a kind of prescription and preparation technology thereof of Chinese medicine preparation, it is characterized in that, the preparation of per 1000 dosage units is prepared from by following proportion raw material:
28~120 parts in 21~90 parts of Gypsum Fibrosum of 9.5~42 portions of Semen Armeniacae Amarums of Herba Ephedrae (peeling is fried)
14~60 parts of 14~60 parts of Rhizoma Cynanchi Stauntoniis of 7~30 parts of Radix Peucedanis of Radix Glycyrrhizae (processed with honey)
7~30 parts of the Radix Stemonae (processed with honey) 14~60 portions of Flos Farfaraees of 14~60 portions of Radix Asteriss (processed with honey)
7~30 parts of Concha Meretricis Seu Cyclinae (forging) 7~30 parts of Exocarpium Citri Grandises of 10.4~46.2 parts of Semen Lepidii (Semen Descurainiae)s (saline is processed)
14~60 parts of Radix Platycodonis 14~60 parts of Pinellia leavens of 14~60 parts of Poria (stir-fry)
14~60 parts of Radix Polygalae (removing heart parching to brown) 14~60 parts of 14~60 parts of Pumexs of Flos Inulae (forging)
108~480 parts in 54~240 portions of Fructus Jujubaes of 14~60 parts of Radix Codonopsis of Fructus Perillae (stir-fry)
14~60 parts of 7~30 parts of Bulbus Allii Macrostemonis of 7~30 parts of Ramulus Cinnamomi of Fructus Schisandrae Chinensis (processed with vinegar) (stir-fry)
7~30 parts of 28~120 parts of Rhizoma Belamcandae of 14~60 parts of Folium Mori of the Radix Paeoniae Alba (wine is processed)
14~60 parts of 3~13.8 parts of Herba Taraxacis of 14~60 parts of Indigo Naturaliss of Radix Scutellariae.
Preferably:
60 parts in 45 parts of Gypsum Fibrosum of 21 portions of Semen Armeniacae Amarums of Herba Ephedrae (peeling is fried)
30 parts of 30 parts of Rhizoma Cynanchi Stauntoniis of 15 parts of Radix Peucedanis of Radix Glycyrrhizae (processed with honey)
15 parts of the Radix Stemonae (processed with honey) 30 portions of Flos Farfaraees of 30 portions of Radix Asteriss (processed with honey)
15 parts of Concha Meretricis Seu Cyclinae (forging) 15 parts of Exocarpium Citri Grandises of 23.1 parts of Semen Lepidii (Semen Descurainiae)s (saline is processed)
30 parts of Radix Platycodonis 30 parts of Pinellia leavens of 30 parts of Poria (stir-fry)
30 parts of Radix Polygalae (removing heart parching to brown) 30 parts of 30 parts of Pumexs of Flos Inulae (forging)
240 parts in 120 portions of Fructus Jujubaes of 30 parts of Radix Codonopsis of Fructus Perillae (stir-fry)
30 parts of 15 parts of Bulbus Allii Macrostemonis of 15 parts of Ramulus Cinnamomi of Fructus Schisandrae Chinensis (processed with vinegar) (stir-fry)
15 parts of 60 parts of Rhizoma Belamcandae of 30 parts of Folium Mori of the Radix Paeoniae Alba (wine is processed)
30 parts of 30 parts of Indigo Naturalis 6.9g of Radix Scutellariae part Herba Taraxacis.
In more than forming, the weight of medicine is calculated with crude drug, and per 1 part can be 1 gram, also can be kilogram or ton, if be unit with gram, this prescription composition can be made into 1000 doses of pharmaceutical preparatioies.Described 1000 doses of fingers, the final drug preparation of making, as make 1000 of soft capsule preparations, drop pill 1000 balls, granule 1000g etc., also can make big packing as granule, as 100~500 bags, specifically can be 100 bags, 125 bags, 200 bags, 250 bags, 500 bags etc., every bag can be used as taking dose 1 time.
More than form, can be made into the preparation of 50~1000 taking doses,, make 125 bags, take 1~2 bag at every turn, can take altogether 62.5~125 times as granule.
More than form to be by weight as proportioning, when producing, can increase or reduce according to corresponding proportion, as large-scale production can be unit with the kilogram, or be unit with the ton, small-scale production can be unit with the milligram also, weight can increase or reduce, but the constant rate of the raw medicinal herbs weight proportion between each composition.
The raw material of Chinese medicine of said ratio extracts processing through new technology of the present invention, obtain the active constituents of medicine of preparation of the present invention, add suitable excipient as required and make suitable medicinal any dosage form, said preparation can be drop pill, capsule, granule, tablet, mixture, fluid extract and extractum, soft extract, powder.
The above new technology of the present invention may further comprise the steps:
Method a:(technology 1.)
(1) gets Semen Lepidii (Semen Descurainiae), Exocarpium Citri Grandis, Flos Inulae, Fructus Schisandrae Chinensis, Ramulus Cinnamomi medical material, adopt steam distillation (or supercritical extraction): medical material is shredded, extract according to an appendix XD of pharmacopeia in 2005 essential oil extraction method, till no longer increasing to the volatile oil height; The volatile oil β-CDBao He, optimised process is: β-CD is 1: 6~12 with the water ratio, and oil is 1: 4~12 with β-CD ratio, and ultrasonic 30~70min gets clathrate;
(2) get Radix Peucedani, Flos Farfarae, Aster tataricus, Fructus Perillae, Semen Armeniacae Amarum (squeezing is deoiled), Rhizoma Belamcandae medical material, soaked 30~90 minutes reheat reflux, extract, 2~6 times with 50~95% ethanol earlier, each 0.5~3 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby;
(3) get Pinellia leaven, Indigo Naturalis directly is used as medicine after breaking into fine powder;
(4) get the residue medical material, decoct with water 2~5 times, each 0.5~3 hour, collecting decoction filtered, and it is standby that filtrate is condensed into thick extractum.
Above active component lumps together the active constituents of medicine into preparation of the present invention, and this active component is suitable for preparing various preparations such as drop pill of the present invention and soft capsule.
Method b:(technology 2.)
(1) getting Semen Lepidii (Semen Descurainiae), Exocarpium Citri Grandis, Flos Inulae, Fructus Schisandrae Chinensis, Ramulus Cinnamomi, Pinellia leaven, Indigo Naturalis medical material beats powder and is used as medicine;
(2) prescription residue medical material is handled the same;
(3) above active component lumps together the active constituents of medicine into preparation of the present invention, and this active component is suitable for preparing various preparations such as tablet of the present invention and capsule.
The active constituents of medicine of the preparation of the present invention that above method obtains can be prepared into preparation of the present invention through further processing.
Preparation of the present invention, different dosage form method difference below is the preparation method of several preferred dosage form.
(1) preparation of drop pill
Drop pill of the present invention, wherein the ratio of active component and adjuvant is 1: 0.5~10, and preferred ratio is 1: 2~4, and most preferred ratio is 1: 3.The above adjuvant be specially molecular weight polyethylene glycol between 400 to 10000 Polyethylene Glycol and their mixture, as PEG400 (PEG400), Macrogol 2000, Macrogol 4000, polyethylene glycol 6000 or their mixture or other suitable other auxiliary elements of making drop pill, as glycerol, gelatin or stearic acid sodium etc.
Following steps are taked in the preparation of drop pill of the present invention:
1. be ready to following raw material: active component, adjuvant and/or other inactive ingredients;
2. with the above-mentioned raw materials mix homogeneously;
3. add the transconversion into heat material, move into the drip irrigation of drop pill machine, medicinal liquid splashes in the liquid sub liquid paraffin by water dropper, removes liquid paraffin, selects ball, promptly.
(2) preparation of soft capsule
Soft capsule preparation of the present invention is that active component and pharmaceutically useful organic solvent and the material of making soft capsule shell are formed.Organic solvent wherein is selected from PEG400, Tween 80, glycerol, propylene glycol, isopropyl alcohol, dehydrogenation soybean oil, vegetable oil, aromatic oil, the material of wherein making soft capsule shell is gelatin or arabic gum, water, plasticizer and antiseptic, the weight ratio of gelatin or arabic gum and plasticizer is 1.0: 0.4~1.0 in the soft capsule shell, and the weight ratio of gelatin and water is 1.0: 0.8~1.2; The content of active component is 50mg~500mg in every soft capsule.
The preparation method of preparation of the present invention, the process following steps:
A. get gelatin, glycerol, pure water adds thermosol, adds an amount of antiseptic, preparation rubber;
B. get active component and be dissolved in organic solvent, add suitable quantity of water, be prepared into soft capsule through encapsulating machine.
(3) preparation process of granule is as follows: with the gained active component, add a certain amount of correctives, filler, lubricant, granulate, promptly get granule.
(4) preparation method of chewable tablet is as follows: with the gained active component, add a certain amount of correctives, filler, lubricant, granulate, and drying, tabletting promptly gets chewable tablet.
Filler described in the preparation of granule, chewable tablet is selected from one or more the mixture in lactose, sucrose, dextrin, starch, microcrystalline Cellulose, mannitol, pregelatinized Starch, sorbitol, the xylitol etc.;
Described correctives one of is selected from Rhizoma et radix valerianae, Fructus Pruni pseudocerasi, Fructus Vitis viniferae, Fructus Citri tangerinae, Fructus Citri Limoniae, Herba Menthae, Fructus Fragariae Ananssae, Fructus Musae, Fructus Ananadis comosi, honey peach essence, maltose alcohol, saccharin sodium, protein sugar, sucrose, aspartame, the stevioside or wherein several mixture;
Suitable lubricant comprises wherein one or more such as magnesium stearate, Pulvis Talci, micropowder silica gel.
Following data declaration beneficial effect of the present invention by experiment:
In order to prove the Clinical feasibility that changes after the technology, we have carried out its main pharmacodynamics, toxicologic study to this medicine, observe its therapeutical effect, and the clinical experimental basis that provides is provided.
1, antitussive effect
Get body weight and be 56 of the Kunming kind white mice of 18~22g, the male and female dual-purpose is divided into 4 groups at random, respectively gastric infusion.Dosage sees Table 1, and the administration volume is 0.6mL/20g, and continuous 7 days, 1h after the last administration, mice is put into inverted bell glass, draw with 25% ammonia spraying and cough, shrink or the breast that contracts with the mice abdominal muscle, magnify mouth simultaneously and be the cough index, mouse cough number of times in the counting 2min the results are shown in Table 1.
Table 1 pair ammonia cause the influence of coughing mice (x ± s, n=14)
Group | Dosage (g/kg) | Cough number of times (inferior) |
Matched group carbetapentane citrate group technology is 2. extractum group of extractum group technology 1. | - 0.05 0.18 0.25 | 29.7±7.8 19.1±7.0 ** 16.4±6.9 *** 17.3±7.6 ** |
Annotate: compare with matched group,
*P<0.01,
* *P<0.001
By table 1 as seen, medicine has significant antitussive effect, and its effect is suitable with carbetapentane citrate.
2, phlegm-dispelling functions
Get body weight and be 48 of the Kunming kind white mice of 18~22g, the male and female dual-purpose, be divided into 4 groups at random, the difference gastric infusion, the administration volume is 0.6mL/20g, continuous 7 days, 30min after the last administration was by body weight lumbar injection 5% phenol red 0.2mL/20g, injection back 30min puts to death mice, peel off the trachea surrounding tissue, cut one section trachea down to the trachea bifurcation, put into the test tube that fills the 2mL normal saline from thyroid cartilage, add 0.1mL 1mol/LNaOH again, survey the OD value in 546nm wavelength place with 721 spectrophotometers, calculate phenol red content, the results are shown in Table 2 according to phenol red standard curve.Phenol red standard curve is: Y=-0.0547+8.717X, r=0.9999.
The influence of the table 2 pair phenol red excretion of mice trachea (x ± s, n=12)
Group | Dosage (g/kg) | The OD value |
Matched group ammonium chloride group technology is 2. extractum group of extractum group technology 1. | - 1 0.18 0.25 | 0.342±0.118 0.506±0.149 ** 0.713±0.276 *** 0.554±0.156 ** |
Annotate: compare with matched group,
*P<0.01,
* *P<0.001
By table 2 as seen, technology 1. extractum group can increase phenol red excretion in the mice trachea section by the utmost point significantly, and its effect is better than the carbetapentane citrate of 1g/kg.
3, antiasthmatic effect (spraying causes the influence of breathing heavily Cavia porcellus to histamine phosphate)
Get body weight and be 40 of the DHP kind Cavia porcelluss of 150g~200g, the male and female dual-purpose, put in the glass bell jar, spray into the 1mg/mL histamine phosphate with ultrasonic nebulizer, the time that the record Cavia porcellus produces asthma, with time of twitching, falling as incubation period, the Cavia porcellus that surpasses 150s will not be selected for use, the Cavia porcellus of selecting is divided into 4 groups at random, each group difference gastric infusion on the 2nd, the administration volume is the 1mL/100g body weight.30min after the administration puts into glass bell jar respectively, and the similarity condition spraying histamine phosphate during by preliminary election, the results are shown in Table 3 at the incubation period that record asthma occurs.
The spraying of table 3 pair histamine phosphate cause the influence of breathing heavily Cavia porcellus (x ± s, n=10)
Group | Dosage (g/kg) | Asthma incubation period (s) |
Matched group aminophylline group technology is 2. extractum group of extractum group technology 1. | - 0.012 0.07 0.09 | 112.8±21.4 233.5±71.4 ** 217.8±96.6 * 145.9±92.3 |
Annotate: compare with matched group,
*P<0.05,
*P<0.01
By table 3 as seen, technology 1. extractum group has certain preventive and therapeutic effect to the Cavia porcellus asthma due to the histamine phosphate, compares the obviously incubation period of prolonged guinea pig asthma with the normal saline matched group.
4, toxicological study
Acute toxicity test shows that rat oral gavage extract of the present invention fails to measure LD
50
Long term toxicity test: rat grouping, extract of the present invention is irritated stomach, every day three times, connect and annotate 90d, the result, administration group rat and control rats movable, search for food, drinking-water, body weight and multinomial observation indexs such as substantial viscera pathologic finding and histopathology detect, result of the test is not all found any toxicity; Hemogram and hepatic and renal function index and the equal no significant difference of matched group.
The blood vessel irritation of this medicine, allergy and hemolytic test all are negative.
In sum, preparation of the present invention, dropping pill formulation particularly of the present invention and soft capsule preparation are the trachea inflammation that a kind of good treatment affection of exogenous wind-cold causes, the cough due to lung-heat, tachypnea asthma is itched in the larynx, accumulation and obstruction of sputum, chest and diaphragm is full vexed, the medicine of old phlegm dyspnea, and change preparation technology, can obviously strengthen clinical efficacies such as its cold expelling antitussive, eliminating phlegm relieving asthma, its hypotoxicity in addition, prolonged application safety, therefore, be worth clinical application.
The specific embodiment:
Further specify the present invention by the following examples, include but not limited to the following example.
Embodiment 1:
The preparation method of drop pill of the present invention:
Prescription:
Herba Ephedrae 9.5g Semen Armeniacae Amarum (peeling is fried) 21g Gypsum Fibrosum 28g
Radix Glycyrrhizae (processed with honey) 7g Radix Peucedani 14g Rhizoma Cynanchi Stauntonii 14g
The Radix Stemonae (processed with honey) 14g Radix Asteris 14g Flos Farfarae (processed with honey) 7g
Concha Meretricis Seu Cyclinae (forging) 10g Semen Lepidii (Semen Descurainiae) 7g Exocarpium Citri Grandis (saline is processed) 7g
Radix Platycodonis 14g Poria 14g Pinellia leaven (stir-fry) 14g
Radix Polygalae (removing heart parching to brown) 14g Flos Inulae 14g Pumex (forging) 14g
Fructus Perillae (stir-fry) 14g Radix Codonopsis 54g Fructus Jujubae 108g
Fructus Schisandrae Chinensis (processed with vinegar) 7g Ramulus Cinnamomi (stir-fry) 7g Bulbus Allii Macrostemonis 30g
The Radix Paeoniae Alba (wine is processed) 14g Folium Mori 28g Rhizoma Belamcandae 7g
Radix Scutellariae 14g Indigo Naturalis 3g Herba Taraxaci 14g
PEG4000 100g
Make 1000 balls
Preparation method:
(1) gets Semen Lepidii (Semen Descurainiae), Exocarpium Citri Grandis, Flos Inulae, Fructus Schisandrae Chinensis, Ramulus Cinnamomi medical material, adopt steam distillation (or supercritical extraction): medical material is shredded, extract according to an appendix XD of pharmacopeia in 2005 essential oil extraction method, till no longer increasing to the volatile oil height; The volatile oil β-CDBao He, optimised process is: β-CD is 1: 8 with the water ratio, and oil is 1: 6 with β-CD ratio, and ultrasonic 30min gets clathrate;
(2) get Radix Peucedani, Flos Farfarae, Aster tataricus, Fructus Perillae, Semen Armeniacae Amarum (squeezing is deoiled), Rhizoma Belamcandae medical material, soaked 30 minutes earlier with 85% ethanol, reheat reflux, extract, 3 times, each 1 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby;
(3) get Pinellia leaven, Indigo Naturalis directly is used as medicine after breaking into fine powder;
(4) get the residue medical material, decoct with water 2 times, each 1.5 hours, collecting decoction filtered, and it is standby that filtrate is condensed into thick extractum.
(5) with above-mentioned extract obtained, the PEG4000 that adds recipe quantity puts into the vessel in heating dissolving, and jolting makes and dissolves into uniform solution, inserts in the fluid reservoir.Keep 80 ℃ the system of dripping temperature, and a control speed, condensed fluid is a liquid paraffin, drips system promptly.
Embodiment 2:
Preparation of soft capsule method of the present invention:
Prescription:
Herba Ephedrae 42g Semen Armeniacae Amarum (peeling is fried) 90g Gypsum Fibrosum 120g
Radix Glycyrrhizae (processed with honey) 30g Radix Peucedani 60g Rhizoma Cynanchi Stauntonii 60g
The Radix Stemonae (processed with honey) 60g Radix Asteris 60g Flos Farfarae (processed with honey) 30g
Concha Meretricis Seu Cyclinae (forging) 46.2g Semen Lepidii (Semen Descurainiae) 30g Exocarpium Citri Grandis (saline is processed) 30g
Radix Platycodonis 60g Poria 60g Pinellia leaven (stir-fry) 60g
Radix Polygalae (removing heart parching to brown) 60g Flos Inulae 60g Pumex (forging) 60g
Fructus Perillae (stir-fry) 60g Radix Codonopsis 240g Fructus Jujubae 480g
Fructus Schisandrae Chinensis (processed with vinegar) 30g Ramulus Cinnamomi (stir-fry) 30g Bulbus Allii Macrostemonis 60g
The Radix Paeoniae Alba (wine is processed) 60g Folium Mori 120g Rhizoma Belamcandae 30g
Radix Scutellariae 60g Indigo Naturalis 13.8g Herba Taraxaci 60g
PEG400 460g
Make 1000
Preparation method:
(1) gets Semen Lepidii (Semen Descurainiae), Exocarpium Citri Grandis, Flos Inulae, Fructus Schisandrae Chinensis, Ramulus Cinnamomi medical material, adopt steam distillation (or supercritical extraction): medical material is shredded, extract according to an appendix XD of pharmacopeia in 2005 essential oil extraction method, till no longer increasing to the volatile oil height; The volatile oil β-CDBao He, optimised process is: β-CD is 1: 8 with the water ratio, and oil is 1: 6 with β-CD ratio, and ultrasonic 30min gets clathrate;
(2) get Radix Peucedani, Flos Farfarae, Aster tataricus, Fructus Perillae, Semen Armeniacae Amarum (squeezing is deoiled), Rhizoma Belamcandae medical material, soaked 30 minutes earlier with 85% ethanol, reheat reflux, extract, 3 times, each 1 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby;
(3) get Pinellia leaven, Indigo Naturalis directly is used as medicine after breaking into fine powder;
(4) get the residue medical material, decoct with water 2 times, each 1.5 hours, collecting decoction filtered, and it is standby that filtrate is condensed into thick extractum.
(5) with above-mentioned extract obtained, add an amount of PEG400 and mix and mixing, add the PEG400 of surplus then, promptly get medicinal liquid.It is standby in addition to join gelatin solution by certain prescription.The condition that control is suitable is regulated content weight, obtains soft capsule in the soft capsule machine.
Embodiment 3:
The preparation method of granule of the present invention:
Prescription:
Herba Ephedrae 52.5g Semen Armeniacae Amarum (peeling is fried) 112.5g Gypsum Fibrosum 150g
Radix Glycyrrhizae (processed with honey) 37.5g Radix Peucedani 75g Rhizoma Cynanchi Stauntonii 75g
The Radix Stemonae (processed with honey) 75g Radix Asteris 75g Flos Farfarae (processed with honey) 37.5g
Concha Meretricis Seu Cyclinae (forging) 58g Semen Lepidii (Semen Descurainiae) 37.5g Exocarpium Citri Grandis (saline is processed) 37.5g
Radix Platycodonis 75g Poria 75g Pinellia leaven (stir-fry) 75g
Radix Polygalae (removing heart parching to brown) 75g Flos Inulae 75g Pumex (forging) 75g
Fructus Perillae (stir-fry) 75g Radix Codonopsis 300g Fructus Jujubae 600g
Fructus Schisandrae Chinensis (processed with vinegar) 37.5g Ramulus Cinnamomi (stir-fry) 37.5g Bulbus Allii Macrostemonis 75g
The Radix Paeoniae Alba (wine is processed) 75g Folium Mori 150g Rhizoma Belamcandae 37.5g
Radix Scutellariae 75g Indigo Naturalis 7g Herba Taraxaci 75g
Make 1000g
Preparation method:
(1) getting Semen Lepidii (Semen Descurainiae), Exocarpium Citri Grandis, Flos Inulae, Fructus Schisandrae Chinensis, Ramulus Cinnamomi, Pinellia leaven, Indigo Naturalis medical material beats powder and is used as medicine;
(2) get Radix Peucedani, Flos Farfarae, Aster tataricus, Fructus Perillae, Semen Armeniacae Amarum (squeezing is deoiled), Rhizoma Belamcandae medical material, soaked 30 minutes earlier with 85% ethanol, reheat reflux, extract, 3 times, each 1 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby;
(3) get the residue medical material, decoct with water 2 times, each 1.5 hours, collecting decoction filtered, and it is standby that filtrate is condensed into thick extractum.
(4) above active component is merged, add aspartame 5.0g, dextrin 240.0g, granulate, drying sprays into essence 5.0g, promptly gets granule 1000g.
Embodiment 4:
The preparation method of chewable tablet of the present invention:
Prescription:
Herba Ephedrae 42g Semen Armeniacae Amarum (peeling is fried) 90g Gypsum Fibrosum 120g
Radix Glycyrrhizae (processed with honey) 30g Radix Peucedani 60g Rhizoma Cynanchi Stauntonii 60g
The Radix Stemonae (processed with honey) 60g Radix Asteris 60g Flos Farfarae (processed with honey) 30g
Concha Meretricis Seu Cyclinae (forging) 46.2g Semen Lepidii (Semen Descurainiae) 30g Exocarpium Citri Grandis (saline is processed) 30g
Radix Platycodonis 60g Poria 60g Pinellia leaven (stir-fry) 60g
Radix Polygalae (removing heart parching to brown) 60g Flos Inulae 60g Pumex (forging) 60g
Fructus Perillae (stir-fry) 60g Radix Codonopsis 240g Fructus Jujubae 480g
Fructus Schisandrae Chinensis (processed with vinegar) 30g Ramulus Cinnamomi (stir-fry) 30g Bulbus Allii Macrostemonis 60g
The Radix Paeoniae Alba (wine is processed) 60g Folium Mori 120g Rhizoma Belamcandae 30g
Radix Scutellariae 60g Indigo Naturalis 13.8g Herba Taraxaci 60g
Make 1000
Preparation method:
(1) getting Semen Lepidii (Semen Descurainiae), Exocarpium Citri Grandis, Flos Inulae, Fructus Schisandrae Chinensis, Ramulus Cinnamomi, Pinellia leaven, Indigo Naturalis medical material beats powder and is used as medicine;
(2) get Radix Peucedani, Flos Farfarae, Aster tataricus, Fructus Perillae, Semen Armeniacae Amarum (squeezing is deoiled), Rhizoma Belamcandae medical material, soaked 30 minutes earlier with 85% ethanol, reheat reflux, extract, 3 times, each 1 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby;
(3) get the residue medical material, decoct with water 2 times, each 1.5 hours, collecting decoction filtered, and it is standby that filtrate is condensed into thick extractum.
(4) above active component is merged, add aspartame 3.0g, mannitol 200.0g, granulation, drying adds magnesium stearate 3.0g, mixing, and tabletting promptly gets 1000 of chewable tablet.
Claims (10)
1, a kind of Chinese medicine preparation is characterized in that per 1000 dosage units are made by the following weight proportion raw material:
28~120 parts in 21~90 parts of Gypsum Fibrosum of 9.5~42 portions of Semen Armeniacae Amarums of Herba Ephedrae (peeling is fried)
14~60 parts of 14~60 parts of Rhizoma Cynanchi Stauntoniis of 7~30 parts of Radix Peucedanis of Radix Glycyrrhizae (processed with honey)
7~30 parts of the Radix Stemonae (processed with honey) 14~60 portions of Flos Farfaraees of 14~60 portions of Radix Asteriss (processed with honey)
7~30 parts of Concha Meretricis Seu Cyclinae (forging) 7~30 parts of Exocarpium Citri Grandises of 10.4~46.2 parts of Semen Lepidii (Semen Descurainiae)s (saline is processed)
14~60 parts of Radix Platycodonis 14~60 parts of Pinellia leavens of 14~60 parts of Poria (stir-fry)
14~60 parts of Radix Polygalae (removing heart parching to brown) 14~60 parts of 14~60 parts of Pumexs of Flos Inulae (forging)
108~480 parts in 54~240 portions of Fructus Jujubaes of 14~60 parts of Radix Codonopsis of Fructus Perillae (stir-fry)
14~60 parts of 7~30 parts of Bulbus Allii Macrostemonis of 7~30 parts of Ramulus Cinnamomi of Fructus Schisandrae Chinensis (processed with vinegar) (stir-fry)
7~30 parts of 28~120 parts of Rhizoma Belamcandae of 14~60 parts of Folium Mori of the Radix Paeoniae Alba (wine is processed)
14~60 parts of 3~13.8 parts of Herba Taraxacis of 14~60 parts of Indigo Naturaliss of Radix Scutellariae.
2, the compound preparation of claim 1 is characterized in that, per 1000 dosage units are made by the following weight proportion raw material:
60 parts in 45 parts of Gypsum Fibrosum of 21 portions of Semen Armeniacae Amarums of Herba Ephedrae (peeling is fried)
30 parts of 30 parts of Rhizoma Cynanchi Stauntoniis of 15 parts of Radix Peucedanis of Radix Glycyrrhizae (processed with honey)
15 parts of the Radix Stemonae (processed with honey) 30 portions of Flos Farfaraees of 30 portions of Radix Asteriss (processed with honey)
15 parts of Concha Meretricis Seu Cyclinae (forging) 15 parts of Exocarpium Citri Grandises of 23.1 parts of Semen Lepidii (Semen Descurainiae)s (saline is processed)
30 parts of Radix Platycodonis 30 parts of Pinellia leavens of 30 parts of Poria (stir-fry)
30 parts of Radix Polygalae (removing heart parching to brown) 30 parts of 30 parts of Pumexs of Flos Inulae (forging)
240 parts in 120 portions of Fructus Jujubaes of 30 parts of Radix Codonopsis of Fructus Perillae (stir-fry)
30 parts of 15 parts of Bulbus Allii Macrostemonis of 15 parts of Ramulus Cinnamomi of Fructus Schisandrae Chinensis (processed with vinegar) (stir-fry)
15 parts of 60 parts of Rhizoma Belamcandae of 30 parts of Folium Mori of the Radix Paeoniae Alba (wine is processed)
30 parts of 30 parts of Indigo Naturalis 6.9g of Radix Scutellariae part Herba Taraxacis.
3, claim 1 or any one Chinese medicine preparation of 2 are drop pill, capsule, granule, tablet, mixture, fluid extract and extractum, soft extract, powder.
4, the Chinese medicine preparation of claim 3 through described raw material is extracted processing, obtains active component, adds suitable adjuvant as required and makes.
5, the Chinese medicine preparation of claim 4 is characterized in that, described active component prepares through following steps:
Method a:(technology 1.)
(1) gets Semen Lepidii (Semen Descurainiae), Exocarpium Citri Grandis, Flos Inulae, Fructus Schisandrae Chinensis, Ramulus Cinnamomi medical material, adopt steam distillation (or supercritical extraction): medical material is shredded, extract according to an appendix XD of pharmacopeia in 2005 essential oil extraction method, till no longer increasing to the volatile oil height; The volatile oil β-CDBao He, optimised process is: β-CD is 1: 6~12 with the water ratio, and oil is 1: 4~12 with β-CD ratio, and ultrasonic 30~70min gets clathrate;
(2) get Radix Peucedani, Flos Farfarae, Aster tataricus, Fructus Perillae, Semen Armeniacae Amarum (squeezing is deoiled), Rhizoma Belamcandae medical material, soaked 30~90 minutes reheat reflux, extract, 2~6 times with 50~95% ethanol earlier, each 0.5~3 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby;
(3) get Pinellia leaven, Indigo Naturalis directly is used as medicine after breaking into fine powder;
(4) get the residue medical material, decoct with water 2~5 times, each 0.5~3 hour, collecting decoction filtered, and it is standby that filtrate is condensed into thick extractum.
Above active component lumps together the active constituents of medicine into preparation of the present invention, and this active component is suitable for preparing various preparations such as drop pill of the present invention and soft capsule.
Method b:(technology 2.)
(1) getting Semen Lepidii (Semen Descurainiae), Exocarpium Citri Grandis, Flos Inulae, Fructus Schisandrae Chinensis, Ramulus Cinnamomi, Pinellia leaven, Indigo Naturalis medical material beats powder and is used as medicine;
(2) prescription residue medical material is handled the same;
(3) above active component lumps together the active constituents of medicine into preparation of the present invention, and this active component is suitable for preparation
Various preparations such as tablet of the present invention and capsule.
6, the Chinese medicine preparation of claim 5 is characterized in that:
Described drop pill, wherein the ratio of active component and adjuvant is 1: 0.5~10, described adjuvant be molecular weight between 400 to 10000 Polyethylene Glycol and their mixture, be selected from PEG400 (or 600), Macrogol 2000, Macrogol 4000, polyethylene glycol 6000 or their mixture.
Its preparation method is: active constituents of medicine and proper auxiliary materials behind 60~115 ℃ of mix homogeneously, are regulated the water dropper size with control drop pill weight, are that the coolant system of dripping forms with dimethicone or liquid paraffin, and coolant temperature is-10~5 ℃.
7, the Chinese medicine preparation of claim 5 is characterized in that:
Described soft capsule, its content is made up of active component and suitable substrate, and wherein the content of active component is 50mg~500mg in every soft capsule; Substrate wherein is selected from wherein one or more of PEG400, Tween 80, glycerol, propylene glycol, isopropyl alcohol, dehydrogenation soybean oil, vegetable oil, aromatic oil, animal wet goods.
Its preparation method is: with active constituents of medicine and proper auxiliary materials mix homogeneously, obtain uniform suspension and/or solution, regulate content weight, compacting, dry getting final product.
8, the Chinese medicine preparation of claim 5 is characterized in that:
The preparation process of described granule is as follows: with above-mentioned extract obtained, add a certain amount of filler, correctives, lubricant, granulate, promptly get granule;
The preparation method of chewable tablet is as follows: with above-mentioned extract obtained, adds a certain amount of filler, correctives, lubricant, granulates, and drying, tabletting promptly gets chewable tablet.
9, the Chinese medicine preparation of claim 8 is characterized in that:
Described filler is selected from one or more the mixture in lactose, sucrose, dextrin, starch, microcrystalline Cellulose, mannitol, pregelatinized Starch, sorbitol, the xylitol etc.;
Described correctives one of is selected from Rhizoma et radix valerianae, Fructus Pruni pseudocerasi, Fructus Vitis viniferae, Fructus Citri tangerinae, Fructus Citri Limoniae, Herba Menthae, Fructus Fragariae Ananssae, Fructus Musae, Fructus Ananadis comosi, honey peach essence, maltose alcohol, saccharin sodium, protein sugar, sucrose, aspartame, the stevioside or wherein several mixture;
Suitable lubricant comprises wherein one or more such as magnesium stearate, Pulvis Talci, micropowder silica gel.
10, the preparation method of any one Chinese medicine preparation of claim 1~9 is characterized in that, the process following steps:
Described raw material of Chinese medicine is extracted processing, obtain active component, add suitable adjuvant and make; Wherein said active component prepares through following steps:
Method a:(technology 1.)
(1) gets Semen Lepidii (Semen Descurainiae), Exocarpium Citri Grandis, Flos Inulae, Fructus Schisandrae Chinensis, Ramulus Cinnamomi medical material, adopt steam distillation (or supercritical extraction): medical material is shredded, extract according to an appendix XD of pharmacopeia in 2005 essential oil extraction method, till no longer increasing to the volatile oil height; The volatile oil β-CDBao He, optimised process is: β-CD is 1: 6~12 with the water ratio, and oil is 1: 4~12 with β-CD ratio, and ultrasonic 30~70min gets clathrate;
(2) get Radix Peucedani, Flos Farfarae, Aster tataricus, Fructus Perillae, Semen Armeniacae Amarum (squeezing is deoiled), Rhizoma Belamcandae medical material, soaked 30~90 minutes reheat reflux, extract, 2~6 times with 50~95% ethanol earlier, each 0.5~3 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby;
(3) get Pinellia leaven, Indigo Naturalis directly is used as medicine after breaking into fine powder;
(4) get the residue medical material, decoct with water 2~5 times, each 0.5~3 hour, collecting decoction filtered, and it is standby that filtrate is condensed into thick extractum.
Above active component lumps together the active constituents of medicine into preparation of the present invention, and this active component is suitable for preparing various preparations such as drop pill of the present invention and soft capsule.
Method b:(technology 2.)
(1) getting Semen Lepidii (Semen Descurainiae), Exocarpium Citri Grandis, Flos Inulae, Fructus Schisandrae Chinensis, Ramulus Cinnamomi, Pinellia leaven, Indigo Naturalis medical material beats powder and is used as medicine;
(2) prescription residue medical material is handled the same;
(3) above active component lumps together the active constituents of medicine into preparation of the present invention, and this active component is suitable for preparing various preparations such as tablet of the present invention and capsule.
Described drop pill, wherein the ratio of active component and adjuvant is 1: 0.5~10, described adjuvant be molecular weight between 400 to 10000 Polyethylene Glycol and their mixture, be selected from PEG400 (or 600), Macrogol 2000, Macrogol 4000, polyethylene glycol 6000 or their mixture.
Its preparation method is: active constituents of medicine and proper auxiliary materials behind 60~115 ℃ of mix homogeneously, are regulated the water dropper size with control drop pill weight, are that the coolant system of dripping forms with dimethicone or liquid paraffin, and coolant temperature is-10~5 ℃.
Described soft capsule, its content is made up of active component and suitable substrate, and wherein the content of active component is 50mg~500mg in every soft capsule; Substrate wherein is selected from wherein one or more of PEG400, Tween 80, glycerol, propylene glycol, isopropyl alcohol, dehydrogenation soybean oil, vegetable oil, aromatic oil, animal wet goods.
Its preparation method is: active constituents of medicine is mixed with proper auxiliary materials, obtain uniform suspension and/or solution, regulate content weight, compacting, dry getting final product.
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CN102188600A (en) * | 2011-04-15 | 2011-09-21 | 中国人民解放军第一医院 | Chinese medicinal preparation for treating tracheitis and preparation method thereof |
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CN102028927B (en) * | 2009-10-06 | 2012-01-11 | 杨福海 | Externally applied emplastrum for treating anxious chronic bronchitis and preparation method thereof |
CN102145144A (en) * | 2011-04-06 | 2011-08-10 | 朱新华 | Traditional Chinese medicine preparation for treatment of asthma |
CN102145144B (en) * | 2011-04-06 | 2012-08-29 | 孙长虹 | Traditional Chinese medicine preparation for treatment of asthma |
CN102188600A (en) * | 2011-04-15 | 2011-09-21 | 中国人民解放军第一医院 | Chinese medicinal preparation for treating tracheitis and preparation method thereof |
CN102188600B (en) * | 2011-04-15 | 2012-07-25 | 中国人民解放军第一医院 | Chinese medicinal preparation for treating tracheitis and preparation method thereof |
CN102362968A (en) * | 2011-10-03 | 2012-02-29 | 周春根 | Traditional Chinese medicine for treating tracheitis |
CN102578703A (en) * | 2012-02-17 | 2012-07-18 | 张婷婷 | Alcoholic extract paste of common coltsfoot flower and preparation method and application thereof |
CN102578703B (en) * | 2012-02-17 | 2014-12-17 | 张婷婷 | Alcoholic extract paste of common coltsfoot flower and preparation method and application thereof |
CN102895375A (en) * | 2012-10-31 | 2013-01-30 | 河南亚卫动物药业有限公司 | Oral liquid for treating livestock respiratory disease and preparation method thereof |
CN104984195A (en) * | 2015-07-10 | 2015-10-21 | 青岛市中心医院 | Traditional Chinese medicinal composition for treating infantile asthma and preparation method for traditional Chinese medicinal composition |
CN105435190A (en) * | 2015-12-30 | 2016-03-30 | 陆学超 | Traditional Chinese medicine composition for treating cold-heat jumble asthma and preparation method of traditional Chinese medicine composition |
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